DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are the currently pending claims. Claim 20 has been withdrawn; and claims 1-29 are hereby under examination.
Election/Restrictions
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/07/2026.
Drawings/Specification
The specification and drawings are objected to as figures 7, 9, and 10 depict an inconsistency with the written description. Figures 7, 9, and 10 appear to depict a cassette embodiment in which the connection mechanism (i.e. hinge) is located above the longitudinal device axis . In contrast, the written description consistently describes the connection mechanism as being positioned below the longitudinal device access in all disclosed embodiments indicating that the invention is defined around the lower side hinge configuration rather than treating hinge placement as an open or optional design choice (Instant Application, [0007]-[0008] and [0054]-[0055]; FIG. 11-12, 14-15). This deviation between the drawings and written specification should be addressed.
Claim Objections
Claim 2 is objected to because of the following informalities:
In claim 2, line 1: the phrase “The apparatus according to claim 1” is improper because claim 1 recites a “cassette,” and the dependent claim should maintain consistent claim terminology (to claim 1 and the remainder of the dependent claims) by reciting “The cassette according to claim 1”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 2 recites “an axis of the cover between the connection mechanism and an outer edge of the cover” in lines 2-3. The claim does not provide objective boundaries for what constitutes the recited “axis” of the cover or how the axis is determined, and further recites “substantially perpendicular” without an objective tolerance. The Examiner is interpreting “axis of the cover between the connection mechanism and an outer edge of the cover” under BRI to mean a line extending from the pivot region at the connection mechanism to the outer edge of the cover, and is interpreting “substantially perpendicular” under BRI to mean perpendicular within a manufacturing or use tolerance sufficient to provide the described open-position geometry.
Claim 7 recites “wherein the opening is configured to orient the side port of the elongated medical device in a substantially vertical direction” in lines 1-2. However, claim 7 depends from claim 5, and claim 5 does not recite an “opening.” The only “opening” recited in the claim set is introduced in claim 6. Accordingly, it is unclear what “the opening” refers to in claim 7, rendering the scope of the claim indefinite. The Examiner is interpreting “the opening” under a broadest reasonable interpretation (BRI) to refer to the opening recited in claim 6, namely, “an opening configured to receive a side port of the elongated medical device,” for purposes of examination, but Applicant is required to amend the claim to provide proper antecedent basis and correct dependency.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-6, 8, 10, 12-14, 16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Falb et al. (US 20180193603 A1), hereto referred as Falb.
Regarding claim 1, Falb teaches that a cassette 222 is used with a robotic catheter system 210 having a robotic mechanism 212 that drives elongated medical devices during a catheter-based procedure: A cassette for use in a robotic drive of a catheter-based procedure system (Falb, FIG. 1; ¶[0045], “a robotic catheter system 210 includes a robotic mechanism 212 robotically moving an elongated medical device”, Falb teaches a catheter-based procedure system (robotic catheter system 210) having a robotic mechanism that performs robotic movement of an elongated medical device; ¶[0054], “During a medical procedure such as a percutaneous coronary intervention (PCI) guide catheter 228 is used to guide other elongated medical devices such as a guide wire and balloon stent catheter into a patient”, Falb teaches the catheter-based procedure context and that the system is used in a catheter-based medical procedure; ¶[0054], “Robotic mechanism 212 drives a guide wire and/or a working catheter such as a balloon stent catheter in and out of a patient”, Falb teaches the “robotic drive” as the robotic mechanism that drives elongated medical devices); the cassette comprising: a housing comprising a cradle configured to receive an elongated medical device having a longitudinal device axis (Falb, FIG. 1–6; ¶[0050], “an elongated medical device such as a guide catheter 228 is operatively secured to robotic mechanism 212 through cassette 222”, Falb teaches cassette 222 as the physical structure through which the elongated medical device is secured and supported within the robotic system, corresponding to the claimed housing; ¶[0050], “an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches that cassette 222 includes structural components forming the cassette body, including a support member that is part of the stationary cassette structure and physically supports the catheter; ¶[0053], “Guide catheter 228 maintains a linear position along its longitudinal axis 248 within cassette 222”, Falb teaches that the elongated medical device is received and held within the cassette along a defined longitudinal device axis; ¶[0053], “In one embodiment longitudinal axis 248 corresponds to the longitudinal axis of cassette 222”, Falb further ties the device axis to the longitudinal orientation of the cassette housing; FIG. 2 and FIG. 4, Falb depicts cassette 222 including a longitudinally extending catheter-receiving channel or cradle formed by the stationary cassette structure (including the support member 245) that physically receives and supports guide catheter 228, with the catheter longitudinal axis positioned above the cradle structure, thereby corresponding to a housing comprising a cradle configured to receive the elongated medical device along its longitudinal device axis); a connection mechanism coupled to the housing at a position below the longitudinal device axis (Falb, ¶[0050], “a Y-connector engagement mechanism 236 including a Y-connector base 238 that is part of cassette 222 and an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches a connection structure in which a movable lid 243 is coupled to a stationary support member 245 that is part of the cassette body forming the housing; ¶[0053], “Guide catheter 228 maintains a linear position along its longitudinal axis 248 within cassette 222”, Falb establishes the longitudinal device axis of the elongated medical device within the cassette; FIG. 2-3, Falb depicts the pivot interface between lid 243 and support member 245 located on the lower portion of the enclosure member 244 relative to the guide catheter centerline, such that the connection mechanism coupling the lid to the housing is positioned below the longitudinal device axis of guide catheter 228; see also FIG. 14-15 for rotated configuration with the hinge); and a cover pivotably coupled to the housing using the connection mechanism (Falb, ¶[0050], “an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches the enclosure member (part of cassette 222) includes a lid, which is a cover component of the housing; ¶[0052], “Y connector holder 238 includes a cover 244 which pivots from an open position to a closed position”, Falb expressly teaches a cover that is pivotable between open and closed positions; FIG. 2-6, Falb depicts the cover 243 pivoting relative to the underlying cassette structure (including support member 245), i.e., a cover pivotably coupled to the housing using the pivot connection).
Regarding claim 2, Falb teaches that the cassette includes a pivoting cover/enclosure that moves between an in-use operational lower position and a raised install position: the cover has a closed position and an open position (Falb, ¶[0050], “an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches that the referenced enclosure member 244 includes lid 243, such that the “cover 244” includes a lid component; ¶[0052], “Y connector holder 238 includes a cover 244 which pivots from an open position to a closed position”, Falb expressly teaches the cover pivots between an open position and a closed position); and wherein when the cover is in the open position an axis of the cover between the connection mechanism and an outer edge of the cover is substantially perpendicular to the housing (Falb, FIG. 2–3, Falb depicts lid 243 in the open position, with lid 243 raised relative to the cassette body that supports guide catheter 228, and extending at a near right angle relative to the catheter-supporting housing such that an axis of lid 243 from its pivot region to its outer edge is substantially perpendicular to the housing).
Regarding claim 3, Falb teaches that the connection mechanism is a hinge (Falb, FIG. 2-4, 6; ¶[0050], “an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches that the referenced enclosure member 244 includes lid 243, such that the “cover 244” includes a lid component; ¶[0052]: “Y connector holder 238 includes a cover 244 which pivots from an open position to a closed position”, Falb teaches a cover that pivots relative to the cassette and the pivoting connection between the cover and the cassette housing corresponds to a hinge connection mechanism permitting pivoting about an axis as depicted in the figures).
Regarding claim 5, Falb teaches that the cassette secures a hemostasis valve coupled to an elongated medical device using an enclosure member including a cover that pivots between an open position and a closed position: wherein the cover includes a recess configured to receive a hemostasis valve coupled to the elongated medical device when the cover is in the open position (Falb, FIG. 1–6B, ¶[0050], “In one embodiment Y-connector 233 is a hemostasis valve that is secured to cassette 222 by a Y-connector engagement mechanism 236 including a Y-connector base 238 that is part of cassette 222 and an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches that the lid 243 is the cover portion of enclosure member 244 associated with the hemostasis valve; Falb, FIG. 2 and FIG. 4, Falb shows the lid 243 including a recessed region shaped to accommodate the hemostasis valve 233 such that, when the lid is pivoted to the open position, the recess receives the hemostasis valve while allowing the hemostasis valve to remain coupled to the elongated medical device without interference from the cover).
Regarding claim 6, Falb teaches that the cassette includes a cover that pivots between an open position and a closed position wherein the cover includes an opening configured to receive a side port of the elongated medical device (Falb, FIG. 1–6B, FIG. 29–30, ¶[0050], “In one embodiment Y-connector 233 is a hemostasis valve that is secured to cassette 222 by a Y-connector engagement mechanism 236 including a Y-connector base 238 that is part of cassette 222 and an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches that the cassette secures the hemostasis valve (Y-connector 233) using enclosure member 244 including lid 243; Falb shows in the cited figures that the lid 243 includes an opening positioned adjacent the received Y-connector 233 so that the side port of the coupled assembly is received through the opening, thereby providing clearance for the side port, under a broadest reasonable interpretation, the elongated medical device as installed in the cassette includes the guide catheter coupled with the hemostasis valve such that the side port of the coupled assembly is a side port of the elongated medical device).
Regarding claim 8, Falb teaches that the cassette secures a hemostasis valve (Y-connector 233) coupled to the elongated medical device using a Y-connector base that is part of the cassette and an enclosure member including a support member: wherein the housing further comprises a recess configured to receive a side port of a hemostasis valve coupled to the elongated medical device (Falb, FIG. 2, FIG. 4, ¶[0050], “In one embodiment Y-connector 233 is a hemostasis valve that is secured to cassette 222 by a Y-connector engagement mechanism 236 including a Y-connector base 238 that is part of cassette 222 and an enclosure member 244 including a lid 243 and a support member 245”, Falb shows the support member 245 as part of the cassette housing structure and depicts, in FIGS. 2 and 4, that the Y-connector base/holder region 238 formed in the housing includes a shaped recess at the “Y” location to accommodate the hemostasis valve geometry including the side port when the hemostasis valve is secured to the cassette; FIG. 29–30, ¶[0081], “The valve body includes a second leg extending at an angle relative to the first leg and in fluid communication with the first leg”, Falb describes the hemostasis valve as having a second leg extending at an angle, which corresponds to the claimed side port, and the recess shown in FIGS. 2 and 4 is configured to receive that angled leg while the hemostasis valve is secured to the cassette).
Regarding claim 10, Falb teaches that a cassette for use in a robotic drive of a catheter-based procedure system comprises (Falb, FIG. 1; ¶[0045], “a robotic catheter system 210 includes a robotic mechanism 212 robotically moving an elongated medical device”, Falb teaches a catheter-based procedure system (robotic catheter system 210) having a robotic mechanism that performs robotic movement of an elongated medical device; ¶[0054], “During a medical procedure such as a percutaneous coronary intervention (PCI) guide catheter 228 is used to guide other elongated medical devices such as a guide wire and balloon stent catheter into a patient”, Falb teaches the catheter-based procedure context and that the system is used in a catheter-based medical procedure; ¶[0054], “Robotic mechanism 212 drives a guide wire and/or a working catheter such as a balloon stent catheter in and out of a patient”, Falb teaches the “robotic drive” as the robotic mechanism that drives elongated medical devices): a housing comprising a cradle configured to receive an elongated medical device having a longitudinal device axis (Falb, FIG. 1–6; ¶[0050], “an elongated medical device such as a guide catheter 228 is operatively secured to robotic mechanism 212 through cassette 222”, Falb teaches cassette 222 as the physical structure through which the elongated medical device is secured and supported within the robotic system, corresponding to the claimed housing; ¶[0050], “an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches that cassette 222 includes structural components forming the cassette body, including a support member that is part of the stationary cassette structure and physically supports the catheter; ¶[0053], “Guide catheter 228 maintains a linear position along its longitudinal axis 248 within cassette 222”, Falb teaches that the elongated medical device is received and held within the cassette along a defined longitudinal device axis; ¶[0053], “In one embodiment longitudinal axis 248 corresponds to the longitudinal axis of cassette 222”, Falb further ties the device axis to the longitudinal orientation of the cassette housing; FIG. 2 and FIG. 4, Falb depicts cassette 222 including a longitudinally extending catheter-receiving channel or cradle formed by the stationary cassette structure (including the support member 245) that physically receives and supports guide catheter 228, with the catheter longitudinal axis positioned above the cradle structure, thereby corresponding to a housing comprising a cradle configured to receive the elongated medical device along its longitudinal device axis); the housing having a distal end and a proximal end (Falb, FIG. 27-28; ¶[0047], “the direction distal is the direction toward the patient and the direction proximal is the direction away from the patient”, Falb defines distal and proximal directions for the robotic mechanism and cassette; ¶[0053], “for at least a certain distance distal cassette 222. In one embodiment longitudinal axis 248 corresponds to the longitudinal axis of cassette 222”, Falb describes a distal region of the cassette along the cassette longitudinal axis, which corresponds to the elongated medical device longitudinal axis, thereby teaching a housing having a distal end and a proximal end along that longitudinal axis); a saddle positioned on the proximal end of the housing, the saddle configured to receive and restrain a hemostasis valve coupled to the elongated medical device, (Falb, FIG. 1–6; ¶[0050], “In one embodiment proximal end 230 of guide catheter 228 is operatively secured to a Y-connector 233 and Y-connector engagement mechanism 236. In one embodiment Y-connector 233 is a hemostasis valve that is secured to cassette 222 by a Y-connector engagement mechanism 236 including a Y-connector base 238 that is part of cassette 222 and an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches a structure on the cassette that receives and secures a hemostasis valve coupled to the elongated medical device at the proximal end of the guide catheter; ¶[0081], “A rotating male luer lock connector is rotatably connected to the valve body proximate the distal port to secure proximal end of guide catheter 228 thereto”, Falb teaches the hemostasis valve is coupled to the elongated medical device at the proximal end, and the cassette secures that coupled hemostasis valve assembly); a connection mechanism coupled to the housing at a position below the longitudinal device axis (Falb, ¶[0050], “a Y-connector engagement mechanism 236 including a Y-connector base 238 that is part of cassette 222 and an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches a connection structure in which a movable lid 243 is coupled to a stationary support member 245 that is part of the cassette body forming the housing; ¶[0053], “Guide catheter 228 maintains a linear position along its longitudinal axis 248 within cassette 222”, Falb establishes the longitudinal device axis of the elongated medical device within the cassette; FIG. 2-3, Falb depicts the pivot interface between lid 243 and support member 245 located on the lower portion of the enclosure member 244 relative to the guide catheter centerline, such that the connection mechanism coupling the lid to the housing is positioned below the longitudinal device axis of guide catheter 228; see also FIG. 14-15 for rotated configuration with the hinge); and a cover pivotably coupled to the housing using the connection mechanism (Falb, ¶[0050], “an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches the enclosure member (part of cassette 222) includes a lid, which is a cover component of the housing; ¶[0052], “Y connector holder 238 includes a cover 244 which pivots from an open position to a closed position”, Falb expressly teaches a cover that is pivotable between open and closed positions; FIG. 2-6, Falb depicts the cover 243 pivoting relative to the underlying cassette structure (including support member 245), i.e., a cover pivotably coupled to the housing using the pivot connection).
Regarding claim 12, Falb teaches the cassette according to claim 10, including a saddle having a U-shape wherein the saddle has a U-shape (Falb, FIG. 2, FIG. 3, QUOTE NOT FOUND, Falb’s FIGS. 2–3 depict the saddle region on the proximal end of the cassette as a U-shaped cradle in which components of the hemostasis valve assembly (including parts 230, 241, and 233) are seated and supported, thereby showing a saddle having a U-shape).
Regarding claim 13, Falb teaches that the cassette includes a pivoting cover/enclosure that moves between an in-use operational lower position and a raised install position: the cover has a closed position and an open position (Falb, ¶[0050], “an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches that the referenced enclosure member 244 includes lid 243, such that the “cover 244” includes a lid component; ¶[0052], “Y connector holder 238 includes a cover 244 which pivots from an open position to a closed position”, Falb expressly teaches the cover pivots between an open position and a closed position); and wherein when the cover is in the open position an axis of the cover between the connection mechanism and an outer edge of the cover is substantially perpendicular to the housing (Falb, FIG. 2–3, Falb depicts lid 243 in the open position, with lid 243 raised relative to the cassette body that supports guide catheter 228, and extending at a near right angle relative to the catheter-supporting housing such that an axis of lid 243 from its pivot region to its outer edge is substantially perpendicular to the housing).
Regarding claim 14, Falb teaches that the connection mechanism is a hinge (Falb, FIG. 2-4, 6; ¶[0050], “an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches that the referenced enclosure member 244 includes lid 243, such that the “cover 244” includes a lid component; ¶[0052]: “Y connector holder 238 includes a cover 244 which pivots from an open position to a closed position”, Falb teaches a cover that pivots relative to the cassette and the pivoting connection between the cover and the cassette housing corresponds to a hinge connection mechanism permitting pivoting about an axis as depicted in the figures).
Regarding claim 16, Falb teaches that the cassette includes a cover that pivots between an open position and a closed position wherein the cover includes an opening configured to receive a side port of the elongated medical device (Falb, FIG. 1–6B, FIG. 29–30, ¶[0050], “In one embodiment Y-connector 233 is a hemostasis valve that is secured to cassette 222 by a Y-connector engagement mechanism 236 including a Y-connector base 238 that is part of cassette 222 and an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches that the cassette secures the hemostasis valve (Y-connector 233) using enclosure member 244 including lid 243; Falb shows in the cited figures that the lid 243 includes an opening positioned adjacent the received Y-connector 233 so that the side port of the coupled assembly is received through the opening, thereby providing clearance for the side port, under a broadest reasonable interpretation, the elongated medical device as installed in the cassette includes the guide catheter coupled with the hemostasis valve such that the side port of the coupled assembly is a side port of the elongated medical device).
Regarding claim 18, Falb teaches that the cassette secures a hemostasis valve (Y-connector 233) coupled to the elongated medical device using a Y-connector base that is part of the cassette and an enclosure member including a support member: wherein the housing further comprises a recess configured to receive a side port of a hemostasis valve coupled to the elongated medical device (Falb, FIG. 2, FIG. 4, ¶[0050], “In one embodiment Y-connector 233 is a hemostasis valve that is secured to cassette 222 by a Y-connector engagement mechanism 236 including a Y-connector base 238 that is part of cassette 222 and an enclosure member 244 including a lid 243 and a support member 245”, Falb shows the support member 245 as part of the cassette housing structure and depicts, in FIGS. 2 and 4, that the Y-connector base/holder region 238 formed in the housing includes a shaped recess at the “Y” location to accommodate the hemostasis valve geometry including the side port when the hemostasis valve is secured to the cassette; FIG. 29–30, ¶[0081], “The valve body includes a second leg extending at an angle relative to the first leg and in fluid communication with the first leg”, Falb describes the hemostasis valve as having a second leg extending at an angle, which corresponds to the claimed side port, and the recess shown in FIGS. 2 and 4 is configured to receive that angled leg while the hemostasis valve is secured to the cassette).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Falb et al. (US 20180193603 A1), hereto referred as Falb, and further in view of Rotem et al. (US 20130116623 A1), hereto referred as Rotem.
Falb teaches claim 1 as described above.
Regarding claim 4, Falb teaches that the cassette includes a cover that pivots between an open position and a closed position further comprising a mechanical locking mechanism configured to hold the cover in the closed position. Falb teaches a cassette having a cover that pivots between an open position and a closed position, but Falb does not expressly teach a mechanical locking mechanism configured to hold the cover in the closed position (Falb, ¶[0052], “Y connector holder 238 includes a cover 244 which pivots from an open position to a closed position. Y connector holder 238 is releasably engaged to a portion of cassette 222 by a release button 246”).
Rotem teaches a medical device enclosure having a housing and a pivotable cover similar in form and function to Falb’s cassette cover, the cover including a locking mechanism that prevents accidental opening, thereby holding the cover closed (Rotem, FIG. 2, ¶[0033], “After assembly of interface unit 32 onto pump 22, a cover 54 may be closed against a rim 52 over the unit for added security. A locking mechanism 55 on the cover prevents accidental opening”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Falb in view of Rotem to further comprise a mechanical locking mechanism configured to hold the cover in the closed position. Such a modification would have been possible by incorporating a latch or other locking mechanism on Falb’s pivoting cover and corresponding mating feature on the cassette housing consistent with Rotem’s locking mechanism on a cover to prevent accidental opening. The benefit of the combination would have been improved retention of the cover in the closed position to reduce inadvertent opening during handling and use and to provide added security for components retained under the cover.
Claims 7, 9, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Falb et al. (US 20180193603 A1), hereto referred as Falb, and further in view of Wenderow et al. (US 20100130987 A1), hereto referred as Wenderow.
Falb teaches claim 1 as described above.
Regarding claim 7, Falb does not explicitly teach that the opening is configured to orient the side port of the elongated medical device in a substantially vertical direction.
Rather, Falb teaches that “up” and “down” are defined relative to gravity (Falb, ¶[0047], “The term up and upper refers to the general direction away from the direction of gravity and the term bottom, lower and down refers to the general direction of gravity”). Falb further teaches that the robotic mechanism including the cassette is mounted to an articulating arm that allows a user to position the robotic mechanism proximate a patient (Falb, ¶[0049], “base 214 is secured to an articulating arm 224 that allows a user to position robotic mechanism 212 proximate a patient”). Falb also teaches that the hemostasis valve (Y-connector 233) is secured to the cassette by an enclosure member including a lid and support member (Falb, ¶[0050], “Y-connector 233 is a hemostasis valve that is secured to cassette 222 by a Y-connector engagement mechanism 236 including a Y-connector base 238 that is part of cassette 222 and an enclosure member 244 including a lid 243 and a support member 245”). As shown in Falb’s figures depicting installation and use configurations (Falb, FIG. 1, FIG. 2, FIG. 14–17, where the connection mechanism is below the axis and the port is in a vertical position), the opening in the cover that receives the side port maintains a fixed orientation of the side port relative to the cassette, and because Falb teaches the cassette is positionable by the articulating arm and defines “up” and “down” with respect to gravity, Falb at least implies that the cassette may be oriented such that the received side port is oriented in a substantially vertical direction in use, as FIGS. 14–17 depict the cassette in a rotated configuration during catheter loading; however, Falb does not expressly clarify whether this orientation reflects an actual use configuration or is presented for depiction purposes.
Wenderow makes this cassette-orientation teaching explicit by disclosing that the articulating arm provides multi-axis pivoting and multiple degrees of freedom to position the cassette in any orientation relative to the patient (Wenderow, ¶[0046], “First knuckle 32 enables articulating arm 18 to pivot about a vertical axis and or a horizontal axis. Second knuckle 34 enables articulating arm 18 to pivot up and down or about a horizontal axis. Articulating arm 18 may have multiple degrees of freedom to position cassette 24 in any orientation relative to the patient for proper positioning”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Falb in view of Wenderow to position the cassette in an orientation relative to gravity such that the opening that receives the side port correspondingly orients the side port in a substantially vertical direction. This would have been possible because Falb already teaches an articulating arm for positioning the robotic mechanism, and Wenderow teaches the specific multi-axis pivoting and degrees of freedom that allow setting a desired cassette orientation. The benefit of the combination would have been improved procedural usability by allowing the clinician to orient the side port as desired for access and line management, including gravity-referenced positioning.
Regarding claim 9, Falb teaches that the cover includes a retaining element (Falb, ¶[0050], “In one embodiment Y-connector 233 is a hemostasis valve that is secured to cassette 222 by a Y-connector engagement mechanism 236 including a Y-connector base 238 that is part of cassette 222 and an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches the hemostasis valve is secured to the cassette by an enclosure member including a lid 243; Falb, FIG. 2 and FIG. 4, Falb depicts the lid 243 including a shaped retaining feature that constrains the angled leg of the hemostasis valve within the housing recess; Falb, FIG. 29–30, ¶[0081], “The valve body includes a second leg extending at an angle relative to the first leg and in fluid communication with the first leg”, Falb’s “second leg” corresponds to the claimed side port and the retaining feature constrains that side port to a fixed orientation relative to the cassette, however Falb only depicts the side port in a vertical orientation in FIGS. 14–17 and does not expressly clarify whether that depicted orientation reflects an actual use configuration or is presented for depiction purposes), but does not explicitly teach that the retaining element is configured to orient the side port of the hemostasis valve in a substantially vertical direction. Rather, Falb teaches that “up” and “down” are defined relative to gravity (Falb, ¶[0047], “The term up and upper refers to the general direction away from the direction of gravity and the term bottom , lower and down refers to the general direction of gravity”). Falb further teaches that the robotic mechanism including the cassette is mounted to an articulating arm that allows a user to position the robotic mechanism proximate a patient (Falb, ¶[0049], “base 214 is secured to an articulating arm 224 that allows a user to position robotic mechanism 212 proximate a patient”). As shown in Falb’s figures (Falb, FIG. 2, FIG. 4), the lid 243 includes a retaining feature that constrains the side port to a fixed orientation relative to the cassette by holding the side port within the housing recess, and FIGS. 14–17 depict a rotated cassette configuration which the side port is oriented upward relative to gravity (where the connection mechanism remains below the elongate axis and the port is in a vertical position). However, Falb does not expressly clarify whether the rotated depiction reflects an actual use configuration or is presented for depiction purposes.
Wenderow makes this cassette-orientation teaching explicit by disclosing that the articulating arm provides multi-axis pivoting and multiple degrees of freedom to position the cassette in any orientation relative to the patient (Wenderow, ¶[0046], “First knuckle 32 enables articulating arm 18 to pivot about a vertical axis and or a horizontal axis. Second knuckle 34 enables articulating arm 18 to pivot up and down or about a horizontal axis. Articulating arm 18 may have multiple degrees of freedom to position cassette 24 in any orientation relative to the patient for proper positioning”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Falb in view of Wenderow to position the cassette in an orientation relative to gravity such that the retaining element of the cover that constrains the side port correspondingly orients the side port of the hemostasis valve in a substantially vertical direction. This would have been possible because Falb already teaches a lid that retains the hemostasis valve side port in a fixed orientation relative to the cassette and teaches an articulating arm for positioning the robotic mechanism, and Wenderow teaches the specific multi-axis pivoting and degrees of freedom that allow setting a desired cassette orientation relative to gravity. The benefit of the combination would have been improved procedural usability by allowing the clinician to orient the hemostasis valve side port as desired for access and line management, including gravity-referenced vertical positioning.
Regarding claim 17, Falb does not explicitly teach that the opening is configured to orient the side port of the elongated medical device in a substantially vertical direction. Rather, Falb teaches that “up” and “down” are defined relative to gravity (Falb, ¶[0047], “The term up and upper refers to the general direction away from the direction of gravity and the term bottom, lower and down refers to the general direction of gravity”). Falb further teaches that the robotic mechanism including the cassette is mounted to an articulating arm that allows a user to position the robotic mechanism proximate a patient (Falb, ¶[0049], “base 214 is secured to an articulating arm 224 that allows a user to position robotic mechanism 212 proximate a patient”). Falb also teaches that the hemostasis valve (Y-connector 233) is secured to the cassette by an enclosure member including a lid and support member (Falb, ¶[0050], “Y-connector 233 is a hemostasis valve that is secured to cassette 222 by a Y-connector engagement mechanism 236 including a Y-connector base 238 that is part of cassette 222 and an enclosure member 244 including a lid 243 and a support member 245”). As shown in Falb’s figures depicting installation and use configurations (Falb, FIG. 1, FIG. 2, FIG. 14–17, where the connection mechanism is below the axis and the port is in a vertical position), the opening in the cover that receives the side port maintains a fixed orientation of the side port relative to the cassette, and because Falb teaches the cassette is positionable by the articulating arm and defines “up” and “down” with respect to gravity, Falb at least implies that the cassette may be oriented such that the received side port is oriented in a substantially vertical direction in use, as FIGS. 14–17 depict the cassette in a rotated configuration during catheter loading; however, Falb does not expressly clarify whether this orientation reflects an actual use configuration or is presented for depiction purposes.
Wenderow makes this cassette-orientation teaching explicit by disclosing that the articulating arm provides multi-axis pivoting and multiple degrees of freedom to position the cassette in any orientation relative to the patient (Wenderow, ¶[0046], “First knuckle 32 enables articulating arm 18 to pivot about a vertical axis and or a horizontal axis. Second knuckle 34 enables articulating arm 18 to pivot up and down or about a horizontal axis. Articulating arm 18 may have multiple degrees of freedom to position cassette 24 in any orientation relative to the patient for proper positioning”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Falb in view of Wenderow to position the cassette in an orientation relative to gravity such that the opening that receives the side port correspondingly orients the side port in a substantially vertical direction. This would have been possible because Falb already teaches an articulating arm for positioning the robotic mechanism, and Wenderow teaches the specific multi-axis pivoting and degrees of freedom that allow setting a desired cassette orientation. The benefit of the combination would have been improved procedural usability by allowing the clinician to orient the side port as desired for access and line management, including gravity-referenced positioning.
Regarding claim 19, Falb teaches that the cover includes a retaining element (Falb, ¶[0050], “In one embodiment Y-connector 233 is a hemostasis valve that is secured to cassette 222 by a Y-connector engagement mechanism 236 including a Y-connector base 238 that is part of cassette 222 and an enclosure member 244 including a lid 243 and a support member 245”, Falb teaches the hemostasis valve is secured to the cassette by an enclosure member including a lid 243; Falb, FIG. 2 and FIG. 4, Falb depicts the lid 243 including a shaped retaining feature that constrains the angled leg of the hemostasis valve within the housing recess; Falb, FIG. 29–30, ¶[0081], “The valve body includes a second leg extending at an angle relative to the first leg and in fluid communication with the first leg”, Falb’s “second leg” corresponds to the claimed side port and the retaining feature constrains that side port to a fixed orientation relative to the cassette, however Falb only depicts the side port in a vertical orientation in FIGS. 14–17 and does not expressly clarify whether that depicted orientation reflects an actual use configuration or is presented for depiction purposes), but does not explicitly teach that the retaining element is configured to orient the side port of the hemostasis valve in a substantially vertical direction. Rather, Falb teaches that “up” and “down” are defined relative to gravity (Falb, ¶[0047], “The term up and upper refers to the general direction away from the direction of gravity and the term bottom , lower and down refers to the general direction of gravity”). Falb further teaches that the robotic mechanism including the cassette is mounted to an articulating arm that allows a user to position the robotic mechanism proximate a patient (Falb, ¶[0049], “base 214 is secured to an articulating arm 224 that allows a user to position robotic mechanism 212 proximate a patient”). As shown in Falb’s figures (Falb, FIG. 2, FIG. 4), the lid 243 includes a retaining feature that constrains the side port to a fixed orientation relative to the cassette by holding the side port within the housing recess, and FIGS. 14–17 depict a rotated cassette configuration which the side port is oriented upward relative to gravity (where the connection mechanism remains below the elongate axis and the port is in a vertical position). However, Falb does not expressly clarify whether the rotated depiction reflects an actual use configuration or is presented for depiction purposes.
Wenderow makes this cassette-orientation teaching explicit by disclosing that the articulating arm provides multi-axis pivoting and multiple degrees of freedom to position the cassette in any orientation relative to the patient (Wenderow, ¶[0046], “First knuckle 32 enables articulating arm 18 to pivot about a vertical axis and or a horizontal axis. Second knuckle 34 enables articulating arm 18 to pivot up and down or about a horizontal axis. Articulating arm 18 may have multiple degrees of freedom to position cassette 24 in any orientation relative to the patient for proper positioning”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Falb in view of Wenderow to position the cassette in an orientation relative to gravity such that the retaining element of the cover that constrains the side port correspondingly orients the side port of the hemostasis valve in a substantially vertical direction. This would have been possible because Falb already teaches a lid that retains the hemostasis valve side port in a fixed orientation relative to the cassette and teaches an articulating arm for positioning the robotic mechanism, and Wenderow teaches the specific multi-axis pivoting and degrees of freedom that allow setting a desired cassette orientation relative to gravity. The benefit of the combination would have been improved procedural usability by allowing the clinician to orient the hemostasis valve side port as desired for access and line management, including gravity-referenced vertical positioning.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Falb et al. (US 20180193603 A1), hereto referred as Falb, and further in view of Blacker (US 20140171863 A1), hereto referred as Blacker.
Falb teaches claim 10 as described above.
Regarding claim 11, Falb teaches the cassette according to claim 10, but does not expressly teach wherein the saddle includes a snap feature to hold the hemostasis valve when the hemostasis valve is positioned in the saddle wherein the saddle includes a snap feature to hold the hemostasis valve when the hemostasis valve is positioned in the saddle. Falb teaches a cassette in a robotic catheter system in which a hemostasis valve (Y-connector 233) is secured to the cassette by a Y-connector engagement mechanism including a base and an enclosure member, but Falb does not expressly teach that the saddle includes a snap feature to hold the hemostasis valve when the hemostasis valve is positioned in the saddle (Falb, FIG. 2, FIG. 4, ¶[0050], “In one embodiment Y-connector 233 is a hemostasis valve that is secured to cassette 222 by a Y-connector engagement mechanism 236 including a Y-connector base 238 that is part of cassette 222 and an enclosure member 244 including a lid 243 and a support member 245”).
Blacker teaches that the base includes a quick release mechanism that releasably secures (i.e., captures/retains) the hemostasis valve to the base, and that the quick release is closed to releasably capture the hemostasis valve (Blacker, ¶[0034]: “Base 32 may include a quick release mechanism to releasably secure hemostasis valve 34 to base32.”; Blacker, ¶[0055]: “Hemostasis valve 34 is secured to base32 with a quick release mechanism 138… Quick release 138 is then closed to releasably capture hemostasis valve 34…”.; FIGS. 16–18).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Falb in view of Blacker to provide the saddle with a snap feature to hold the hemostasis valve when the hemostasis valve is positioned in the saddle, because Blacker expressly teaches a quick release retention mechanism that releasably secures/captures a hemostasis valve on a base (i.e., a snap/clip-type retention feature). This would have been possible by incorporating a quick release style snap retention feature on Falb’s hemostasis valve receiving region to releasably retain the hemostasis valve while still permitting intentional removal as taught by Blacker. The benefit of the combination would have been improved retention and procedural usability by securely holding the hemostasis valve in place while allowing convenient removal and replacement when needed.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Falb et al. (US 20180193603 A1), hereto referred as Falb, and further in view of Jarnagin et al. (US 20110300010 A1), hereto referred as Jarnagin.
Falb teaches claim 10 as described above.
Regarding claim 15, Falb teaches a cassette having a cover that pivots between an open position and a closed position (as shown in claim 10 above), but does not expressly teach that the cassette further comprises a magnet configured to hold the cover in the closed position. Jarnagin teaches a medical enclosure comprising a housing, a cover pivotally coupled to the housing, and a magnetic latching mechanism configured to hold the cover in the closed position (Jarnagin, ¶[0043], “Pivoting door 140 is mounted to hinge brackets 144 for pivoting the door toward and away from rotor assembly 120”; ¶[0049], “Latching mechanism(s) may also be provided to provide positive positioning of the door when closed… Many different types of latching mechanisms may be used including, for example, magnetic latches… magnets may be mounted in posts 165… with additional magnets mounted in a door framework or posts 168… with the magnets serving a latching function to maintain the door in the closed position until sufficient force is exerted to break the magnetic attraction”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Falb in view of Jarnagin to further comprise a magnet configured to hold the cover in the closed position. Such a modification would have been possible by incorporating a magnetic latch on Falb’s pivoting cover and a corresponding magnetic element on the cassette housing, consistent with Jarnagin’s magnetic latching arrangement for retaining a pivoting door in a closed position. The benefit of the combination would have been improved reliability in maintaining the cover in the closed position during use, thereby reducing inadvertent opening of the cover during catheter-based procedures.
Conclusion
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791